Source Document Specialist

Sarah Cannon Research Institute • Nashville, TN

11d

About The Position

The Source Document Specialist supports the Study Coordinator on a daily basis and helps ensure study activities follow company SOPs and applicable GCP and ICH regulations and guidelines. The role supports industry trial data deadlines and obtains source documentation for patients enrolled in clinical trials. It also assists with case report form completion and query resolution as needed; obtains medical records, including research charts; creates and maintains tracking spreadsheets for medical record and research chart accountability; and maintains and archives study administrative files. The specialist works with Tennessee Oncology medical record departments to ensure record accountability and with Iron Mountain to locate archived records. The role includes regular meetings with the project manager and assessing adherence to Sarah Cannon SOPs, GCP, and ICH regulations and guidelines.

Requirements

• Associate degree.
• At least 2 years of experience working in a health care organization; oncology experience preferred.
• Knowledge of scientific, medical, and regulatory terms.
• Knowledge of GCP and Good Manufacturing Practice (GMP).
• Detail-oriented.
• Excellent written and oral English skills.

Nice To Haves

• Bachelor’s degree preferred.
• Oncology experience preferred.
• Healthcare experience, clinical trials support, or pharmaceutical industry experience preferred.

Responsibilities

• Support the Study Coordinator on a daily basis.
• Ensure activities are conducted according to company SOPs and applicable GCP and ICH regulations and guidelines.
• Support the Study Coordinator in meeting industry trial data deadlines.
• Obtain source documentation for patients enrolled in clinical trials.
• Assist with case report form completion and query resolution as needed.
• Assist the Study Coordinator in obtaining medical records, including research charts.
• Create and maintain spreadsheets for medical record and research chart accountability.
• Maintain and archive study administrative files.
• Work with Tennessee Oncology medical record departments to ensure accountability of records.
• Work with Iron Mountain to locate archived records.
• Meet regularly with the project manager.
• Assess adherence to Sarah Cannon SOPs, GCP, and ICH regulations and guidelines.

Benefits

• Comprehensive benefits supporting physical, mental, and financial well-being.
• Competitive compensation package.
• An annual bonus or long-term incentive opportunities may be offered.

What This Job Offers

• Job Type: Full-time
• Education Level: Associate degree